Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Bronchial Microbiology Brush

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Bronchial Microbiology Brush see related information
Date Initiated by Firm December 28, 2021
Date Posted March 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-0711-2022
Recall Event ID 89488
510(K)Number K893729  
Product Classification endoscopic cytology brush - Product Code FDX
Product Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.
Code Information Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/01/2022 through 12/01/2026. Catalog Number 4310, Package DI M84943100, Package DI Number M84943101; Catalog Number 4320, Package DI M84943200, Package DI Number M84943201; Lot Numbers: H12-16-112 H12-16-113 H12-16-114 H01-17-002 H01-17-003 H01-17-004 H01-17-005 H01-17-101 H01-17-134 H01-17-135 H01-17-136 H02-17-044 H02-17-045 H02-17-046 H02-17-047 H02-17-048 H03-17-113 H03-17-114 H03-17-115 H03-17-116 H03-17-117 H03-17-233 H03-17-234 H03-17-235 H03-17-236 H03-17-237 H03-17-238 H05-17-119 H05-17-120 H05-17-121 H05-17-122 H05-17-123 H05-17-124 H06-17-142 H06-17-143 H06-17-144 H06-17-145 H07-17-112 H07-17-113 H07-17-114 H07-17-115 H08-17-127 H08-17-128 H08-17-129 H08-17-130 H08-17-131 H08-17-269 H08-17-270 H08-17-271 H08-17-272 H08-17-273 H09-17-102 H09-17-103 H09-17-104 H10-17-053 H10-17-056 H10-17-057 H10-17-058 H10-17-059 H10-17-060 H10-17-061 H11-17-146 H11-17-147 H11-17-148 H11-17-149 H11-17-150 H11-17-151 H12-17-120 H12-17-121 H12-17-122 H12-17-123 H12-17-124 H02-18-001 H02-18-002 H02-18-003 H02-18-004 H02-18-005 H02-18-209 H02-18-210 H02-18-211 H02-18-212 H02-18-219 H02-18-220 H02-18-221 H03-18-176 H03-18-177 H03-18-178 H03-18-179 H03-18-180 H04-18-038 H04-18-039 H04-18-040 H04-18-151 H04-18-152 H04-18-153 H04-18-154 H04-18-155 H04-18-156 H04-18-157 H05-18-177 H05-18-178 H05-18-179 H05-18-180 H06-18-111 H06-18-112 H06-18-113 H06-18-114 H07-18-017 H07-18-018 H07-18-019 H07-18-021 H07-18-020 H08-18-070 H08-18-071 H08-18-073 H08-18-072 H08-18-206 H08-18-207 H08-18-208 H10-18-117 H10-18-118 H10-18-120 H10-18-121 H10-18-119 H11-18-133 H11-18-134 H11-18-135 H11-18-136 H11-18-137 H01-19-023 H01-19-024 H01-19-025 H01-19-026 H01-19-027 H12-18-086 H12-18-087 H12-18-088 H12-18-089 H12-18-090 H01-19-178 H01-19-179 H01-19-180 H01-19-181 H01-19-182 H01-19-183 H02-19-184 H02-19-185 H02-19-186 H02-19-187 H02-19-188 H02-19-189 H02-19-190 H04-19-067 H04-19-068 H04-19-069 H04-19-070 H04-19-071 H04-19-072 H04-19-073 H05-19-102 H05-19-103 H05-19-104 H05-19-160 H05-19-161 H05-19-162 H05-19-163 H05-19-164 H06-19-001 H06-19-003 H06-19-004 H06-19-002 H06-19-310 H06-19-311 H06-19-312 H06-19-313 H06-19-314 H06-19-315 H06-19-316 H06-19-317 H07-19-129 H07-19-130 H07-19-131 H07-19-132 H07-19-133 H07-19-134 H08-19-176 H08-19-177 H08-19-178 H08-19-179 H08-19-180 H09-19-113 H09-19-114 H09-19-115 H09-19-116 H10-19-104 H10-19-105 H10-19-107 H10-19-106 H10-19-108 H11-19-120 H11-19-121 H11-19-122 H01-20-008 H01-20-009 H01-20-010 H01-20-011 H01-20-012 H01-20-013 H01-20-207 H01-20-208 H01-20-209 H01-20-210 H01-20-211 H01-20-212 H01-20-213 H02-20-125 H02-20-126 H02-20-127 H02-20-128 H02-20-129 H03-20-169 H03-20-170 H03-20-171 H03-20-173 H03-20-172 H04-20-097 H04-20-098 H04-20-099 H04-20-100 H04-20-101 H04-20-120 H04-20-121 H04-20-122 H04-20-123 H04-20-124 H05-20-109 H05-20-110 H05-20-111 H05-20-112 H05-20-113 H05-20-114 H05-20-115 H05-20-116 H05-20-117 H05-20-118 H06-20-033 H06-20-034 H06-20-035 H06-20-036 H06-20-037 H07-20-060 H07-20-061 H07-20-062 H07-20-063 H08-20-102 H08-20-103 H08-20-104 H08-20-105 H08-20-106 H08-20-107 H09-20-040 H09-20-041 H09-20-042 H09-20-043 H10-20-074 H10-20-075 H10-20-076 H10-20-077 H10-20-078 H11-20-096 H11-20-097 H11-20-098 H11-20-099 H11-20-100 H12-20-160 H12-20-161 H12-20-162 H12-20-163 H12-20-164 H01-21-105 H01-21-106 H01-21-107 H01-21-108 H01-21-110 H01-21-109 H02-21-047 H02-21-048 H02-21-049 H02-21-050 H02-21-051 H03-21-158 H03-21-159 H03-21-160 H03-21-161 H03-21-162 H05-21-137 H05-21-138 H05-21-139 H05-21-140 H06-21-148 H06-21-149 H06-21-150 H06-21-151 H06-21-152 H07-21-005 H07-21-006 H07-21-007 H07-21-008 H07-21-009 H07-21-133 H07-21-134 H07-21-135 H07-21-136 H07-21-137 H07-21-138 H12-16-115 H12-16-116 H02-17-131 H02-17-132 H02-17-133 H02-17-134 H02-17-135 H02-17-136 H03-17-118 H03-17-119 H03-17-120 H04-17-030 H04-17-031 H04-17-032 H04-17-033 H05-17-098 H05-17-099 H05-17-100 H05-17-101 H06-17-146 H06-17-147 H06-17-148 H06-17-149 H07-17-116 H07-17-117 H07-17-118 H07-17-119 H08-17-132 H08-17-133 H08-17-134 H08-17-135 H08-17-274 H08-17-275 H08-17-276 H08-17-277 H10-17-062 H11-17-109 H11-17-110 H11-17-111 H11-17-112 H12-17-125 H12-17-126 H12-17-127 H12-17-128 H12-17-129 H02-18-006 H02-18-007 H02-18-008 H02-18-009 H02-18-010 H02-18-213 H02-18-214 H02-18-215 H03-18-181 H03-18-182 H03-18-183 H04-18-158 H04-18-159 H05-18-181 H05-18-182 H05-18-183 H07-18-022 H07-18-023 H08-18-082 H08-18-083 H08-18-084 H08-18-204 H08-18-205 H10-18-114 H10-18-115 H10-18-116 H11-18-138 H11-18-139 H11-18-140 H01-19-184 H01-19-185 H01-19-186 H01-19-187 H01-19-188 H01-19-189 H01-19-190 H01-19-191 H01-19-192 H01-19-193 H01-19-194 H01-19-195 H01-19-196 H01-19-197 H01-19-198 H03-19-087 H03-19-088 H03-19-089 H04-19-124 H04-19-125 H04-19-126 H04-19-127 H06-19-318 H06-19-319 H06-19-320 H07-19-135 H07-19-136 H07-19-137 H08-19-173 H08-19-174 H08-19-175 H09-19-117 H09-19-118 H09-19-119 H10-19-109 H10-19-111 H01-20-014 H01-20-015 H01-20-016 H10-19-110 H01-20-214 H01-20-215 H01-20-216 H01-20-217 H03-20-174 H03-20-175 H03-20-176 H03-20-177 H05-20-119 H05-20-120 H05-20-121 H06-20-038 H06-20-039 H07-20-064 H07-20-065 H09-20-037 H09-20-038 H11-20-101 H11-20-102 H12-20-165 H12-20-166 H01-21-111 H01-21-112 H03-21-064 H03-21-065 H07-21-143 H07-21-144
Recalling Firm/
Manufacturer		 Hobbs Medical, Inc.
8 Spring St
Stafford Springs CT 06076-1505
Manufacturer Reason
for Recall		 The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
FDA Determined
Cause 2		 No Marketing Application
Action URGENT MEDICAL DEVICE RECALL notification letters were sent to customers beginning 12/28/21. Actions requested on your part: 1. Read the Description of the problem section. 2. Immediately identify and set aside all product listed herein in a manner that ensures the affected product will not be used and will be returned to Hobbs Medical. 3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs Medical Customer Service, return via Fax at 860-684-7574, or email to CustomerService@HobbsMedical.com. 4. Pass on this notice to anyone in your facility that needs to be informed according to your internal notification procedures. 5. If any product listed below has been forwarded to another facility, contact that facility to arrange return. 6. Maintain awareness of this notice until all product listed above has been returned to Hobbs Medical. The following assistance is available: -For questions related to the issue or product replacement, please contact Hobbs Medical Customer Service. -For questions related to product return please contact Hobbs Medical Customer Service Return instructions are provided on the Acknowledgement Form. -For questions related to the Acknowledgement Form and its return, please contact Hobbs Customer Service at 1-800-344-6227
Quantity in Commerce 38,357 devices
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FDX and Original Applicant = HOBBS MEDICAL, INC.
-
-